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Wednesday, February 8, 2017

Even After Stacking the Deck on EPA's Expert Panel, Monsanto May Still Lose the Battle Over Glyphosate - Unless the EPA Goes Down

In the fall of this year, as the EPA ramped up its expert panel to review glyphosate, and held hearings on whether or not the herbicide is carcinogenic, Monsanto struck a blow to the panel's integrity, via the pro-pesticide industry group CropLife America.

One of the experts CropLife America called out was Dr. Peter Infante, an epidemiologist educated at University of Michigan, who later became a leading cancer expert with OSHA. He has impeccable credentials, serving for 24 years at OSHA where he researched cancer and other risks to workers from asbestos, arsenic, benzene, cadmium, formaldehyde and lead. He has served on review panels for IARC (the UN's top cancer agency) and many other prestigious scientific bodies.

The CropLife America letter objected to Infante's refusal to use industry-provided research in assessments and to the fact that he had testified against Monsanto in court cases involving other substances.

"To tell you the truth, I was taken by surprise," Dr. Infante said, when I interviewed him over the phone last week. "I had been on many working groups over the years, including the EPA." The CropLife America letter impugned his reputation.

"When I heard about the letter, I discussed it with the EPA and was told not to worry about it. I wanted to write the EPA a response letter about but they discouraged me, telling me after our discussion that it was not important." Nonetheless, he responded to the accusations with a four page letter of his own, sent to the EPA on Oct. 21.

At this point, Infante, who had never studied the literature on glyphosate before (it was not his area of specialization), had spent over a month looking at the studies the EPA had sent to him and other expert panel members.

The EPA's initial 227 page report, disseminated to all the panelists as a foundation for their review, and written by EPA staff, concluded that glyphosate was not carcinogenic.

Infante had planned on attending the panel meeting until just days before the December meeting, when the EPA informed him he would not be on the panel.

"I was shocked," he said. "I was told my presence might give the appearance of being biased against pesticides. But I had never taken a public position on glyphosate. I understand the pressures the EPA is under, but..."

"I worked for the government for 27 years, and now I was apparently considered a threat to the EPA evaluation."

The timing? Just weeks after the presidential election.

House Rep. Lamar Smith, a 16 term Congressman
from Texas who heads the House Committee on Science,
Space and Technology

Chris Portier has been targeted by Smith, and his brother, Kenneth Portier, was the other EPA expert on the panel that CropLife America wanted to remove from the glyphosate review proceedings.

Chris Portier, now with the Environmental Defense Fund, worked with IARC on setting up guidelines for cancer risk assessment. He is a former director of the National Center for Environmental Health at the Centers for Disease Control and Director of the Agency for Toxic Substances and Disease Registry.

IARC = THE GOLD STANDARD

Infante's own observations of IARC were revealing. "IARC is not a rogue outfit," he told me. "It's the United Nations' expert cancer committee. It is comprised of scientists from all over the world, and it is a fairly cautious and conservative group."

In fact, Infante said, in his experience IARC is sometimes overly cautious. He wrote a commentary on an IARC evaluation of benzene, a chemical which he has in-depth knowledge about, since he's been studying it since 1976. "I wrote that IARC underplayed significant studies," he said. IARC will be re-evaluating benzene in 2017.

While many lawsuits are now pending against Monsanto over glyphosate, brought by law firms representing agricultural workers who say glyphosate was the cause of their cancer, Infante has declined all offers to participate in these suits. "I've turned them all down," he said.

However, he is troubled by the tactics Monsanto is using against the IARC ruling that glyphosate is carcinogenic.

"The industry attack on by countries around the world IARC - that it is using studies that are poor quality - is wrong," he said. "IARC is the gold standard that is cited by countries around the world in determining the causes of cancer in order to inform their citizens about cancer risks. On the basis of animal cancer study results and human cancer study results, IARC concluded that glyphosate is 'probably carcinogenic to humans.'"

Infante also objects to the industry using confidential studies with regulatory agencies. "We can't evaluate the methodology of those studies," he said. "We don't know how long the animals in these studies lived. Did the researchers conduct pathologies on all the organs of the animals? Was there an expert panel to evaluate the pathology?"

"IARC, in comparions, uses only studies that have been published in peer-reviewed journals or from major agencies, like OSHA, CDC, etc.). These are publicly available and transparent."

6 OUT OF 10 EPA REVIEW PANEL MEMBERS CONCLUDED THERE IS EVIDENCE OF GLYPHOSATE ASSOCIATED WITH A CANCER RISK TO HUMANS

Even though he was not a sitting member of the EPA expert panel, Dr. Infante, who lives outside D.C., came to the four days of meeting in mid December to witness the proceedings.

I listened to some of them on the audio livestream online, as did many others, but was unable to tell who was speaking (the experts' discussions online did not identify speakers each time someone spoke). While the EPA stated in mid December (in an email to me) that the transcripts from the public hearings would be made available on the hearings web site, to date they have not been posted.

So I asked Dr. Infante how he thought the panel was leaning on the fourth day, when the ten sitting experts discussed the issue of whether there was evidence that glyphosate was carcinogenic. (Their final rulings are not due until later in 2017.)

"Well the only two epidemiologists on the panel both felt there was some evidence for it causing non-Hodgkin lymphoma in humans," he said. "By the end of the fourth day, ten panel members expressed an opinion about the overall evidence of cancer. Six concluded that there was evidence of glyphosate as a carcinogen."

"A majority of the panel members who expressed an opinion concluded that there was evidence of cancer."

Infante criticized the agency for including 17 studies on genotoxicity that relied on Monsanto's review (and not the EPA's). "The EPA was using Monsanto's conclusions on these 17 studies," he said. "That's an abnegation of their responsibility."

"When I was with the federal government that never would have happened on my watch. I've looked at a lot of epidemiological studies and the evidence for non-Hodgkin lymphoma is fairly strong that ag workers are at risk."

The EPA panelists who are still on the panel are scheduled to publish their findings later this year. However attempts by the Trump administration and the new nominee to head the EPA, Scott Pruitt, might end the review panel altogether.

All the more important then, to note that even after kicking Infante off the panel, as well as issuing a pro-glyphosate EPA advisory report, the EPA's expert panel may still find that Monsanto's herbicide is associated with a cancer risk to humans.APPENDIX

Dr. Infante's Bio (as published by EPA)Dr. Infante is currently the Managing Member of Peter F. Infante Consulting, LLC, an
organization dedicated to research and analysis of occupational and environmental health issues. Between 2002 and 2011, he was Adjunct Professor, and Professorial Lecturer, of Environmental
and Occupational Health at the George Washington University, School of Public Health,
Washington, He was previously the Director, Office of Standards Review, Health Standards
Program and Director of the Office of Carcinogen Identification and Classification at OSHA. During his 24 years in OSHA, he played a major role in determining cancer and other risks to
workers during the development of standards for a number of toxic substances, including
asbestos, arsenic, benzene, cadmium, ethylene oxide, formaldehyde, lead and MDA. Prior to
working at OSHA, he was employed by the National Institute for Occupational Safety and
Health (NIOSH) where he conducted epidemiological studies related to a number of carcinogens
found in the workplace including, benzene, beryllium and vinyl chloride. He has served as an
expert consultant in epidemiology for: the National Toxicology Program’s (NTP) Report on
Carcinogens (RoC); for Working Groups of the International Agency for Research on Cancer
(IARC); the EPA Science Advisory Board (SAB) Chemical Assessment Advisory Committee;
and as an expert on cancer risk from asbestos exposure for the World Trade Organization (WTO)
in Geneva, Switzerland. He has testified before the U.S. Congress on numerous occasions about
chemical pollution and the causes of cancer. He is a Fellow of the American College of
Epidemiology and the Collegium Ramazzini. Dr. Infante received his D.D.S. degree from the
Ohio State University, and his Dr.P.H. degree from the University of Michigan, School of Public
Health, Department of Epidemiology.

Wines We Cover

We publish information about wines grown from certified organic or Biodynamic vineyards that are generally made with sulfites (which are usually added in small amounts to preserve the wine).

That includes these certification types:

ORGANIC WINE CERTIFICATIONS

• Made with Organic Grapes

Vineyards: certified organic

Vinification: less than 100 ppm of sulfites (i.e. a normal range)

Winery: certified organic facility

Labeling: front or back label

• Ingredients: Organic Grapes

Vineyards: certified organic

Vinification: up to 350 ppm of sulfites (same as for any non organic wine)

Labeling: back label only

BIODYNAMIC® CERTIFICATIONS

• Biodynamic Wine

Vineyards: certified biodynamic

Yeasts: native

Vinification: less than 100 ppm of sulfites; no additives of any kind

Winery: certified biodynamic facility

Labeling: front or back label; Demeter logo may appear

• Made with Biodynamic Grapes

Vineyards: certified biodynamic

Yeasts: native or organic

Vinification: less than 100 ppm of sulfites; limited number of additives permitted

Winery: certified biodynamic facility

Labeling: front or back

Note: unlike organically grown wines, for which there is a category called "Ingredients: Organic Grapes," wines sourced from biodynamic grapes may not make any biodynamic claim on the bottle label. Bottle labeling is reserved for Demeter certified wines only.

SULFITES IN CONTEXT

According to U.C. Davis, the average among all wines in the U.S. (as well as globally) is 80 ppm.

WHAT THE USDA CALLS ORGANIC WINES

Unlike any other nation, the U.S. oddly imposes a no sulfite restriction on wines in order for them to be called Organic Wine. These wines are also called NSA or NAS wines (which stands for "No Sulfites Added" or "No Added Sulfites.")

From the above description, one can see that there are in fact three types of organically grown wines:

1. Organic Wine (less than 15% of all organically grown wine)

2. Made with Organic Grapes

3. Ingredients: Organic Grapes

The vast majority of wines from organic grapes are labeled Made with Organic Grapes, Ingredients: Organic Grapes or are blended with nonorganic grapes and unlabeled.

Fine winemakers do not generally make wine without sulfites and a number of large wine retailers like BevMo do not sell wine in the category of "USDA Organic Wine."

With rare exceptions, this blog does not cover what the USDA calls "Organic Wine."

We are hopeful that the USDA will revise the categorization of organically grown wines and make NSA or NAS wines a category of their own.

This would put the U.S. in accord with the rest of the world, where "Organic Wine" means a wine from certified grapes made within limits on sulfites (generally under 100-150 ppm).